A Randomized Trial of Induction Versus Expectant Management (ARRIVE)
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ClinicalTrials.gov Identifier: NCT01990612 |
Recruitment Status :
Completed
First Posted : November 21, 2013
Results First Posted : January 25, 2019
Last Update Posted : February 21, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Labor and Delivery | Procedure: Elective Induction of Labor | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6106 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized trial of 6000 women at 38 weeks 0 days to 38 weeks 6 days randomized to one of two arms: elective induction of labor between 39 weeks 0 days and 39 weeks 4 days; or expectant management (unless a medical indication arises) until at least 40 weeks 5 days. |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Induction in Nulliparous Women at 39 Weeks to Prevent Adverse Outcomes: A Randomized Controlled Trial |
Study Start Date : | March 2014 |
Actual Primary Completion Date : | November 2017 |
Actual Study Completion Date : | January 2018 |
Arm | Intervention/treatment |
---|---|
No Intervention: Expectant Management
Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.
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Elective Induction of Labor
Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days
|
Procedure: Elective Induction of Labor
Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score < 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises. |
- Composite of Severe Neonatal Morbidity and Perinatal Mortality [ Time Frame: delivery through 72 hours after birth ]
Includes any one of:
- Perinatal death
- Need for respiratory support within 72 hours after birth
- Apgar score of 3 or less at 5 minutes
- Hypoxic-ischemic encephalopathy
- Seizure
- Infection (confirmed sepsis or pneumonia)
- Meconium aspiration system
- Birth trauma (bone fracture, neurologic injury or retinal hemorrhage)
- Intracranial or subaleal hemorrhage
- Hypotension requiring vasopressor support
- Perinatal Death (Component of Primary Outcome) [ Time Frame: antepartum pregnancy period through hospital discharge ]Perinatal death includes antepartum stillbirth, intrapartum stillbirth and neonatal death
- Number of Participant Infants Requiring Respiratory Support (Component of Primary Outcome) [ Time Frame: Delivery through discharge ]Respiratory support includes mechanical ventilation, continuous positive airway pressure or high flow nasal cannula and cardiorespiratory resuscitation
- Number of Infants With Apgar Score ≤3 at 5 Minutes (Component of Primary Outcome) [ Time Frame: Delivery through 5 minutes after birth ]The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.
- Number of Infants With Neonatal Hypoxic-ischemic Encelphalopathy (Component of Primary Outcome) [ Time Frame: delivery through discharge ]
- Number of Infants With Neonatal Seizure (Component of Primary Outcome) [ Time Frame: Delivery through discharge ]
- Number of Infants With Neonatal Infection (Component of Primary Outcome) [ Time Frame: delivery through discharge ]Neonatal infection includes confirmed sepsis and/or confirmed pneumonia
- Number of Infants With Meconium Aspiration Syndrome (Component of Primary Outcome) [ Time Frame: Delivery through discharge ]
- Number of Infants With Birth Trauma (Component of Primary Outcome) [ Time Frame: During the Delivery process ]Birth trauma includes clavicular, skull or other fracture; brachial plexus palsy, facial nerve palsy, retinal hemorrhage or vocal cord paralysis
- Number of Infants With Intracranial or Subgaleal Hemorrhage (Component of Primary Outcome) [ Time Frame: delivery through disharge ]Intracranial or subgaleal hemorrhage includes Intraventricular hemorrhage grades III or IV, subdural hematoma, subarachnoid hematoma, and subgaleal hematoma
- Hypotension Requiring Vasopressor Support (Component of Primary Outcome) [ Time Frame: delivery through discharge ]
- Number of Participants With Cesarean Delivery [ Time Frame: delivery ]
- Number of Participants Who Had Uterine Incisional Extension at Cesarean Delivery [ Time Frame: delivery ]Incisional extensions at cesarean section, including J shape or T shape; or cervical traumas
- Participants Who Had Operative Vaginal Delivery [ Time Frame: delivery ]
- Number of Participants Who Had Chorioamnionitis [ Time Frame: at any time from randomization through delivery ]Chorioamnionitis, defined as a clinical diagnosis before delivery
- Number of Participants With Third or Fourth Degree Perineal Laceration [ Time Frame: delivery ]
- Number of Maternal Deaths [ Time Frame: from randomization to hospital discharge ]Maternal death at anytime between randomization and hospital discharge.
- Number of Participants Admitted to Intensive Care Unit (ICU) [ Time Frame: delivery through hospital discharge ]Admission of the participant to the intensive care unit (ICU)
- Number of Participants Experiencing Hypertensive Disorder of Pregnancy [ Time Frame: Randomization to hospital discharge ]
- Number of Participants With Postpartum Hemorrhage [ Time Frame: delivery through hospital discharge ]
defined as any of the following:
- Transfusion
- Non-elective hysterectomy
- Use of two or more uterotonics other than oxytocin
- Other surgical interventions such as uterine compression sutures, uterine artery ligation, embolization, hypogastric ligation, or balloon tamponade
- Curettage
- Labor Agentry Scale Scores [ Time Frame: Between 6 hours after delivery and 8 weeks after delivery ]Scores on the Labor Agentry Scale range from 29 to 203, with higher scores indicating greater perceived control during childbirth; included are women who had spontaneous labor, labor that started spontaneously but then was augmented, or induced labor.
- Labor Pain Scores [ Time Frame: During labor and delivery ]Labor pain was scored according to a 10-point Likert scale, with higher scores indicating greater pain; included are women who had spontaneous labor, labor that started spontaneously but then was augmented, or induced labor.
- Number of Participants With Maternal Postpartum Infection [ Time Frame: delivery through discharge ]
Defined as any of the following:
- Clinical diagnosis of endometritis
- Wound reopened for hematoma, seroma, infection or other reasons
- Cellulitis requiring antibiotics
- Pneumonia
- Pyelonephritis
- Bacteremia - unknown source
- Septic pelvic thrombosis
- Number of Participants With Venous Thromboembolism [ Time Frame: delivery through discharge ]Maternal deep venous thrombosis or pulmonary embolism
- Number of Participants With Indications for Cesarean Delivery [ Time Frame: Labor and delivery ]Number of participants with indications for cesarean delivery including dystocia, non-reassuring fetal status or other indication
- Duration of Respiratory Support [ Time Frame: delivery through hospital discharge ]including ventilator, CPAP, high-flow nasal cannula (HFNC)
- Number of Infants With Cephalohematoma [ Time Frame: delivery through hospital discharge ]
- Shoulder Dystocia [ Time Frame: delivery ]
- Number of Infants Who Had Transfusion of Blood Products or Blood [ Time Frame: delivery through hospital discharge ]
- Number of Infants With Hyperbilirubinemia [ Time Frame: delivery through discharge ]Hyperbilirubinemia requiring phototherapy or exchange transfusion
- Number of Infants With Neonatal Hypoglycemia [ Time Frame: delivery through discharge ]glucose < 35 mg/dl and requiring IV therapy
- Number Infants Admitted to NICU or Intermediate Care [ Time Frame: delivery through hospital discharge ]Number infants admitted to intensive care unit (NICU) or intermediate care unit
- Number of Hours on the Labor and Delivery Unit [ Time Frame: Hours from admission to L&D to discharge from L&D ]Median duration of stay in labor and delivery unit
- Maternal Postpartum Length of Hospital Stay [ Time Frame: delivery through hospital discharge ]
- Neonatal Length of Hospital Stay [ Time Frame: delivery through hospital discharge ]
- Number of Participants With Indications for Operative Vaginal Delivery [ Time Frame: Labor and delivery ]Number of participants with indications for operative vaginal delivery including dystocia, non-reassuring fetal status and other indications
- Number of Participants and Breastfeeding Status at 4-8 Weeks After Delivery [ Time Frame: 4-8 weeks after delivery ]Breastfeeding status includes breastfeeding, breastfeeding and formula feeding, or formula feeding

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Nulliparous - no previous pregnancy beyond 20 weeks
- Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age.
- Gestational age at randomization between 38 weeks 0 days and 38 weeks 6 days inclusive based on clinical information and evaluation of the earliest ultrasound.
Exclusion Criteria:
- Project gestational age at date of first ultrasound is > 20 weeks 6 days
- Plan for induction of labor prior to 40 weeks 5 days
- Plan for cesarean delivery or contraindication to labor
- Breech presentation
- Signs of labor (regular painful contractions with cervical change)
- Fetal demise or known major fetal anomaly
- Heparin or low-molecular weight heparin during the current pregnancy
- Placenta previa, accreta, vasa previa
- Active vaginal bleeding greater than bloody show
- Ruptured membranes
- Cerclage in current pregnancy
- Known oligohydramnios, defined as AFI < 5 or MVP < 2
- Fetal growth restriction, defined as EFW < 10th percentile
- Known HIV positivity because of modified delivery plan
- Major maternal medical illness associated with increased risk for adverse pregnancy outcome (for example, any diabetes mellitus, lupus, any hypertensive disorder, cardiac disease, renal insufficiency)
- Refusal of blood products
- Participation in another interventional study that influences management of labor at delivery or perinatal morbidity or mortality
- Delivery planned elsewhere at a non-Network site

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990612
United States, Alabama | |
University of Alabama - Birmingham | |
Birmingham, Alabama, United States, 35233 | |
United States, California | |
Stanford University | |
Stanford, California, United States, 94305-5317 | |
United States, Colorado | |
University of Colorado | |
Denver, Colorado, United States, 80045 | |
United States, Illinois | |
Northwestern University-Prentice Hospital | |
Chicago, Illinois, United States, 60611 | |
United States, New York | |
Columbia University-St. Luke's Hospital | |
New York, New York, United States, 10032 | |
United States, North Carolina | |
University of North Carolina - Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599 | |
Duke University | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Case Western Reserve University | |
Cleveland, Ohio, United States, 44109 | |
Ohio State University Hospital | |
Columbus, Ohio, United States, 43210 | |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
Magee Womens Hospital of UPMC | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Rhode Island | |
Brown University | |
Providence, Rhode Island, United States, 02905 | |
United States, Texas | |
Dept of OB/GYN, Southwestern Medical Center, University of Texas | |
Dallas, Texas, United States, 75235-9032 | |
University of Texas - Galveston | |
Galveston, Texas, United States, 77555 | |
University of Texas - Houston | |
Houston, Texas, United States, 77030 | |
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States, 84132 |
Study Director: | Menachem Miodovnik, MD | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | |
Principal Investigator: | Rebecca Clifton, PhD | The George Washington University Biostatistics Center | |
Study Chair: | William Grobman, MD | Northwestern University |
Documents provided by The George Washington University Biostatistics Center:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Induction of labor Expectant management of labor 39 weeks gestation |